Adolescent Inpatient Tobacco and ENDS Intervention

Sponsor

Children's Mercy Hospital Kansas City (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936099

Collaborator

National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)

144

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

Condition or Disease	Intervention/Treatment	Phase
Vaping Smoking	Behavioral: E-cigarette & Tobacco Use Treatment Intervention	N/A

Detailed Description

Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital

Anticipated Study Start Date :

Jul 10, 2023

Anticipated Primary Completion Date :

Jul 10, 2025

Anticipated Study Completion Date :

Jul 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Participants will complete the baseline survey and receive an informational brochure
Experimental: Intervention Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey	Behavioral: E-cigarette & Tobacco Use Treatment Intervention The behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.

Arm

Intervention/Treatment

No Intervention: Control

Participants will complete the baseline survey and receive an informational brochure

Experimental: Intervention

Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey

Behavioral: E-cigarette & Tobacco Use Treatment Intervention

The behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.

Outcome Measures

Primary Outcome Measures

Self-reported 30-day abstinence [3 month follow up]
Cessation verified with biochemical verification of a saliva sample

Secondary Outcome Measures

Acceptability of intervention in pediatric inpatient hospital setting [End of study (enrollment completion)]
Ratings from participants, participants' parent, and providers on perceived acceptability (i.e., satisfaction) of the intervention
Feasibility of intervention [End of study (enrollment completion)]
Ratings from participants, participants' parent, and providers on perceived feasibility (i.e., utility or practicability) of the intervention
Fidelity of intervention delivered by a health educator [End of study (enrollment completion)]
Extent of fidelity achieved in intervention delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Admitted to the hospital
Screens positive for past 30 day e-cigarette use

Exclusion Criteria:

Age is less than 14 years or over 21 years
Not comfortable speaking/reading English
Too ill to participate
Severe psychiatric illness
Too developmentally delayed/cognitively impaired

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Mercy Hospital Kansas City
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Abbey Masonbrink, MD, MPH, Children's Mercy Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbey Masonbrink, Pediatric Hospitalist, MD MPH, Children's Mercy Hospital Kansas City

ClinicalTrials.gov Identifier:

NCT05936099

Other Study ID Numbers:

STUDY00002116
5K23DA055736-02

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abbey Masonbrink, Pediatric Hospitalist, MD MPH, Children's Mercy Hospital Kansas City

Vaping

Adolescents

Cessation

Study Results

No Results Posted as of Jul 7, 2023